Clinical trial · Interventional
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery
NCT02622880CI-TRIAL-00020085completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunomodulatory supplement | Dietary Supplement | — | UNRESOLVED |
| IMPACT | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- : IMPACT
- description
- along 10 days before surgery
- interventionNames
- Dietary Supplement: IMPACT
- type
- EXPERIMENTAL
- label
- immunomodulatory supplement
- description
- along 10 days before surgery
- interventionNames
- Dietary Supplement: immunomodulatory supplement
Primary outcomes (1)
- measure
- Number of postoperative infections
- timeFrame
- 30 days after surgery
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women \>18 years * Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery) * Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent * Patients who do not participate in other clinical trials Exclusion Criteria: * Patients with an active infectious process at the time of the study. * Patients who have undergone radiotherapy / chemotherapy prior to surgery. * Subjects diagnosed with Type I Diabetes Mellitus * Subjects who used oral hypoglycemic agents or insulin. * Patients with severe kidney disease, heart, respiratory or liver. * Patients with autoimmune diseases or immunosuppressive drugs used. * Subjects with dementia, mental illness or diminished cognitive function. * Subjects who refuse oral supplements. * Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study. * Subjects with morbid obesity (BMI ≥ 40 kg / m2). * Pregnant or breastfeeding * Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.
References
Publications (0)
Data not yet available
No reference posted for this study.